Explained: Why is Dapoxetine ‘Banned’ in the US?

Dapoxetine has been approved and is available as a prescription medication in some countries, but it is banned in the US.

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) that was initially developed as an antidepressant. However, during clinical trials, researchers discovered that it had a significant side effect – delaying ejaculation.

This led to further research and the development of dapoxetine as a treatment for premature ejaculation (PE). In some countries, dapoxetine has been approved and is available as a prescription medication under brand names like Priligy.

Why Isn’t Dapoxetine Approved in the U.S.?

There are several reasons why dapoxetine has not received FDA approval for the treatment of premature ejaculation in the United States:

Safety and Efficacy Concerns:

One of the primary reasons for the lack of FDA approval is concerns about the safety and efficacy of dapoxetine. Clinical trials have shown mixed results in terms of its effectiveness, with some studies demonstrating positive outcomes, while others show limited benefits. Additionally, the drug is associated with side effects, including nausea, dizziness, and headache.

Risk-Benefit Assessment:

The FDA carefully evaluates the risk-benefit profile of any medication before granting approval. In the case of dapoxetine, the agency has raised concerns about the balance between potential benefits (improved control over ejaculation) and risks (side effects and long-term safety).

Regulatory Hurdles:

The regulatory process for drug approval in the U.S. is rigorous and time-consuming. Manufacturers of dapoxetine may not have been willing to invest the resources required to complete the necessary clinical trials and meet FDA requirements, given the uncertainties surrounding its approval.


Some healthcare providers in the U.S. may prefer to explore alternative treatments for premature ejaculation before considering dapoxetine. These alternatives include behavioral therapy, topical anesthetics, and off-label use of other medications.

Benefits of Dapoxetine:

Despite the concerns and lack of FDA approval, dapoxetine has shown promise as a treatment for premature ejaculation in some studies. For some men, it may provide an effective solution to a distressing condition that can negatively impact their sexual and emotional well-being. The benefits of dapoxetine include:

Increased Control:

Dapoxetine can help men gain better control over their ejaculation, potentially leading to improved sexual satisfaction for both partners.

Improved Quality of Life:

Premature ejaculation can lead to anxiety, stress, and a diminished sense of self-esteem. Dapoxetine may offer relief from these emotional burdens.

Non-Invasive Treatment:

Dapoxetine is taken orally, making it a non-invasive treatment option compared to some other treatments for premature ejaculation.

Risks and Concerns:

While dapoxetine has potential benefits, it is essential to consider its risks and concerns as well:

Side Effects:

Dapoxetine can cause side effects, including nausea, dizziness, and headache. These side effects can be bothersome for some individuals and may affect their willingness to continue treatment.

Limited Long-Term Data:

Long-term safety data for dapoxetine are limited, and concerns exist about its safety profile with extended use.

Inconsistent Efficacy:

Dapoxetine’s effectiveness varies from person to person, and it may not be a suitable treatment for everyone with premature ejaculation.


In countries where dapoxetine is available, it can be relatively expensive, making it inaccessible to some individuals.

Regulatory Landscape:

The regulatory landscape surrounding dapoxetine varies from country to country. As mentioned earlier, some countries have approved dapoxetine for the treatment of premature ejaculation, while others have not. In the U.S., the FDA’s stringent approval process has resulted in the lack of approval for dapoxetine.

It is worth noting that in the absence of FDA approval, some healthcare providers may still prescribe dapoxetine off-label to individuals who could benefit from it. Off-label use is legal and common for many medications, but it involves using a drug for a purpose not approved by the FDA.

Alternatives to Dapoxetine:

In the United States, healthcare providers and individuals seeking treatment for premature ejaculation have several alternatives to dapoxetine:

Behavioral Therapy:

Techniques such as the stop-start method and the squeeze technique can help improve ejaculatory control through behavioral interventions.

Topical Anesthetics:

Some topical numbing agents can be applied to the penis to reduce sensitivity and delay ejaculation. However, these products should be used with caution and under the guidance of a healthcare professional.

Prescription Medications:

Some antidepressants, particularly SSRIs like sertraline and paroxetine, can be prescribed off-label to treat premature ejaculation. These medications can have side effects, so their use should be carefully monitored.


Talking to a therapist or counselor about the psychological aspects of premature ejaculation can be beneficial in some cases.


Dapoxetine is not banned in the United States, but it has not received FDA approval for the treatment of premature ejaculation. The reasons for this lack of approval include safety and efficacy concerns, regulatory hurdles, and alternative treatment options.

While dapoxetine may offer benefits for some individuals, it is essential to consider its risks and limitations before seeking it as a treatment for premature ejaculation. It is advisable for individuals experiencing premature ejaculation to consult with a healthcare provider to explore suitable treatment options based on their specific needs and circumstances.